Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207648490275 Date of Approval: 06/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title In vivo precision of digital interocclusal registration for full arch and quadrant arch scans
Official scientific title In vivo precision of digital interocclusal registration for full arch and quadrant arch scans
Brief summary describing the background and objectives of the trial Background: Complete digital workflow including both digital scans and virtual interocclusal records can help the clinician saving time and effort and improve the quality of the final restorations. Aim of the study: This study aimed to assess the precision of virtual articulation with intraoral scanner in vivo for full arch and complete arch scans. Methods: five participants will be recruited and participate in both study group. For group I, full arch digital scans will be made using Medit i700 intraoral scanner followed by virtual models articulation with bilateral bite registration. For Group II, the participants will receive quadrant scans and the models will be virtually articulated with digital buccal scan. The articulated models will be saved as STL files and a 3D processing software will be used for matching the STL files obtaining (n=30) superimpositions for each study group. The mean value of the deviations between articulated models will be calculated with the software to measure the precision. Results: Measurements will be collected and statistically analyzed.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied dental occlusion analysis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/07/2022
Actual trial start date 01/07/2022
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 01/08/2022
Anticipated target sample size (number of participants) 9
Actual target sample size (number of participants) 9
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional dental bite registration 36 times as 6 per participant 36 times as 6 per participant Conventional bite registration with poly vinylsiloxane bite registration material 9 Active-Treatment of Control Group
Experimental Group digital bite registraion 39 times as 6 per participant 39 times as 6 per participant digital bite registration with intraoral scanner 9
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
full dentate patients normal TMJ condition no need for restorations or other dental treatments adult patients aged between 19 and 44 teeth in need for dental treatment partially edentulous cases TMJ disorders Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2022 the scientific research ethics committee at faculty of dentistry Alexandria University
Ethics Committee Address
Street address City Postal code Country
Champlion St., Azarita Alexandria 003 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Precision of bite registration endpoint outcome
Secondary Outcome precision of in vivo bite registration with intraoral scanner endpoint
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Private clinic Camb de cezar st Alexandria 03 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Noha Morsy Metwaly Camb De Cezar st. Alexandria 003 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Ahmed Mohsen Menecy Camb De Cezar St. Alexandria 003 El Salvador Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha Morsy nohamorsy.nm88@yahoo.com 00201062744333 Camb De Cezar st
City Postal code Country Position/Affiliation
Alexandria 003 Egypt lecturer at faculty of dentistry Alexandria University
Role Name Email Phone Street address
Public Enquiries Ahmed Menecy Ahmedmenecy@gmail.com 00201006367797 Camb De Cezar St.
City Postal code Country Position/Affiliation
Alexandria 003 Egypt Faculty of dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohammed El Kateb prof_elkateb@yahoo.com 00201122644189 Azarita
City Postal code Country Position/Affiliation
Alexandria 003 Egypt Professor at faculty of dentistry alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IDP sharing will be available for all include participants after deidentification Study Protocol 6 months the data will be available for seekers either through the corresponding author by contacting through e mail or through journal page after publication according to the policy of the journal and/or publisher
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information